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NCT00379340 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
A Phase 3 study of Stage III Kidney Wilms Tumor and Stage IV Kidney Wilms Tumor, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 395
- Enrollment target
- 20
- Study locations
NCT00379340: Active Phase 3 study of Stage III Kidney Wilms Tumor and Stage IV Kidney Wilms Tumor, sponsored by Children's Oncology Group.
NCT00379340 is a Phase 3 study of Stage III Kidney Wilms Tumor and Stage IV Kidney Wilms Tumor that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 395 participants, below the 438-participant average among 3 other Stage III Kidney Wilms Tumor trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00379340, a Phase 3 study of Stage III Kidney Wilms Tumor and Stage IV Kidney Wilms Tumor, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 395 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.
Primary Outcome
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin Hydrochloride
- PROCEDURE Conventional Surgery
- BIOLOGICAL Dactinomycin
- RADIATION 3-Dimensional Conformal Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Valley Children's Hospital - Madera
- Children's Oncology Group - Oakland
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
- USA Health Strada Patient Care Center - Mobile
Arizona
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Arkansas
- Arkansas Children's Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2007-04-30 |
| Est. Completion | 2026-11-18 |
| Phase | Phase 3 |
What the registry record for NCT00379340 still lists
NCT00379340 is an interventional study that assigns participants to a tested intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap, below the 438-participant average among 3 other Stage III Kidney Wilms Tumor trials with a reported enrollment target (10% lower).
The record links to 2 conditions, with Stage III Kidney Wilms Tumor appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00379340 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00379340 about?
NCT00379340 is a clinical study titled "Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor". This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the ce...
What is the current status of trial NCT00379340?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 395 participants. The study started on 2007-04-30. Estimated completion is 2026-11-18.
What conditions does trial NCT00379340 study?
This clinical trial studies the following conditions: Stage III Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor.
What interventions are being tested in trial NCT00379340?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Conventional Surgery (PROCEDURE), Dactinomycin (BIOLOGICAL), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT00379340?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00379340 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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